LADARVISION 4000 EXCIMER LASER SYSTEM
FDA premarket approval P970043/S020 · decided 2006-05-01
Approval details
- PMA number
- P970043
- Supplement
- S020
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LADARVISION 4000 EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Alcon Laboratories
- Date received
- 2005-05-27
- Decision date
- 2006-05-01
- Days to decision
- 339 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR THE LADARVISION 4000 EXCIMER LASER SYSTEM AND THE LADAR 6000 EXCIMER LASER SYSTEM. THESE DEVICES USE A 6.5 MM OPTICAL ZONE AND A 9.0 TREATMENT ZONE AND ARE INDICATED FOR WAVE-FRONT GUIDED CUSTOMCORNEA LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF HYPEROPIA AND HYPEROPIC ASTIGMATISM OF +0.75 D TO LESS THAT +5.00 D OF SPHERE WITH UP TO -3.00 D OF CYLINDER (WHICH HAS A MAGNITUDE LESS THAN OR EQUAL TO THE SPHERE IN MINUS CYLINDER CONVENTION) AND U
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| NEXT GENERATION LASER (K062624) | Alcon Laboratories | 2007-11-05 |
| SMALL VOLUME SYRINGE (K062865) | Alcon Laboratories | 2007-08-23 |
| RGP MULTI-PURPOSE SOLUTION ID 100136 (K000148) | Alcon Laboratories | 2000-04-11 |
| OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP (K984573) | Alcon Laboratories | 1999-09-16 |
| OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER (K990480) | Alcon Laboratories | 1999-05-10 |
| MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 (K984575) | Alcon Laboratories | 1999-01-14 |
| OPTI-ONE MULTI-PURPOSE SOLUTION (K983973) | Alcon Laboratories | 1998-12-18 |
| MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 (K983780) | Alcon Laboratories | 1998-12-18 |